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The company aims to replace traditional surgery for bladder tumor removal with a simpler in-office procedure that could lower costs, shorten recovery time, and reduce risks for patients.
By Shula Rosen
Israeli American medical technology firm CAPS Medical has received a major boost in its bid to change how bladder cancer is treated.
The company announced that its PlasmaSure system has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration for use in patients with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Developed between Santa Monica, California, and Netanya, Israel, the PlasmaSure platform uses non-thermal atmospheric plasma energy to selectively destroy tumors while sparing surrounding healthy tissue.
The technology can be delivered through standard minimally invasive tools—such as cystoscopes—making it possible for doctors to perform tumor ablation in an outpatient setting instead of in an operating room.
CAPS Medical recently completed its first human trial, treating about 70 tumors with what the company described as “durable complete response rates” over both short- and long-term follow-up.
The study reported no damage to healthy tissue and no significant side effects, with several patients treated without the need for general anesthesia.
The company aims to replace traditional surgery for bladder tumor removal, known as transurethral resection (TURBT), with a simpler in-office procedure that could lower costs, shorten recovery time, and reduce risks for patients.
“Receiving Breakthrough Device Designation is a strong validation of the clinical need for a safer, more accessible solution for NMIBC patients,” Ilan Uchitel, CEO and co-founder of CAPS Medical, said in a press release. He said the recognition from the FDA will allow for priority review and more direct communication with regulators, paving the way for faster market approval and potential early reimbursement under the Centers for Medicare & Medicaid Services’ coverage pathway for emerging technologies.
The company is now preparing for pivotal clinical trials and expanding its U.S. operations to support commercialization. Beyond bladder cancer, CAPS Medical is advancing research into applications for other solid tumors, including those in the lung, esophagus, stomach, and prostate.
With its dual base in Israel and the United States, CAPS Medical’s goal is to make tumor ablation a safer, more precise, and more accessible treatment option for cancer patients worldwide.
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